NCT06363877

Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections

Wound Irrigation and Peritoneal Lavage With Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter randomized controlled trial of 1100 patients to evaluate the superiority of combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine compared to normal saline in male and female patients between the ages of 18 and 80 years old undergoing emergency laparotomies with Centers for Disease Control (CDC) class 2 and 3 wounds.

Detailed description

The main objective is stated in the Brief Summary. The secondary objective is to determine the safety and adverse events of povidone-iodine compared to normal saline for irrigation in patients undergoing emergency laparotomies for CDC class 2 and 3 wounds. The main questions this study aims to answer are: * Does combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine decrease surgical site infections? * Is combined intraoperative wound irrigation and intraoperative peritoneal lavage with dilute aqueous povidone-iodine safe to use compared to normal saline? * Are there any adverse effects of combined intraoperative wound irrigation and intraoperative peritoneal lavage with dilute aqueous povidone-iodine usage on CDC class 2 and 3 wounds compared to normal saline? Subjects will be followed over 18 months with follow-up of each patient up to 30 days postoperatively. Randomization of patients will occur prior to going to beginning the emergency laparotomy.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Povidone-Iodine	Peritoneal lavage: With the fascia open, the peritoneum will be washed out with 1L of dilute aqueous povidone-iodine solution allowing the solution to sit in the peritoneum for 2 minutes. This is followed by suctioning of the povidone-iodine solution then wash-out with 2L of normal saline followed by suctioning of the normal saline. Wound Irrigation: With the fascia closed, the wound will be irrigated with 500mL povidone-iodine solution, suctioned, then washed-out with 500 mL normal saline.
DRUG	Normal Saline	Peritoneal lavage: With the fascia open, the peritoneum will be washed out with 1L of normal saline allowing the solution to sit in the peritoneum for 2 minutes. This is followed by suctioning of the solution, wash-out with 2L of normal saline, followed by suctioning of the normal saline. Wound Irrigation: With the fascia closed, the wound will be irrigated with 500mL normal saline solution, suctioned, then washed-out with 500 mL normal saline.

Timeline

• Start date: 2024-06-03
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2024-04-12
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study